Research groups at Shinshu University and the University of Tokyo will begin Phase I / II clinical trials aimed at assessing safety and efficacy in patients with malignant melanoma.So far, we have been conducting clinical development of a third-generation herpesvirus for cancer treatment, which has a function of strongly inducing anticancer immunity.
Virotherapy is a method of directly destroying cancer cells by the growth of the virus that infects the cancer cells, and is considered to be an innovative treatment method.A virus designed using genetic engineering technology is used so that it grows well only in cancer cells and not in normal cells at all.
The University of Tokyo has been promoting the clinical application of the third-generation herpesvirus for cancer treatment (G47Δ) since 2009.This virus was developed by artificially modifying three viral genes of herpes simplex virus type 1 (herpes labialis virus).A high therapeutic effect was confirmed in a doctor-initiated clinical trial (Phase II study) completed last year for glioblastoma (a type of malignant brain tumor).
T-hIL12 used this time is the world's first anti-cancer immunostimulatory third-generation herpesvirus for the treatment of cancer. A gene for interleukin 47 (IL-12), which is a factor that strongly stimulates immunity, is incorporated into the basic skeleton of G12Δ, and a function that strongly induces anticancer immunity is added.In anticipation of the practical application of G47Δ, the research group has begun to develop next-generation anticancer virus products with various functions added to G47Δ, and clinical trials of T-hIL12 will be started as the first clinical application. ..
In this clinical trial, in addition to the safety (Phase I) of T-hIL1 alone for malignant melanoma, the efficacy (Phase II) can be examined with a single clinical trial report. As a domestically-produced genetically modified anti-cancer virus product following G12Δ, and as the first next-generation anti-cancer virus product with various functions, the company aims to approve manufacturing and marketing as soon as possible.
